Reported Mar 8, 2023 · Terminated
Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b)…
Accord Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2 |
| 2 | 100-count bottle, NDC 16729-278-01, UPC 3 16729 27801 10 Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 |
| 3 | India |
- Lot codes and dates
11 of 11 products
Products covered by this recall # Product as published 1 P2005474, Exp 9/30/2023 2 P2100001, Exp 12/31/2023 3 P2100789, P2100790, Exp 1/31/2024 4 P2101319, Exp 2/28/2024 5 P2102147, P2102148, Exp 3/31/2024 6 P2104084, Exp 6/30/2024 7 P2105410, P2107233, P2105411, Exp 7/31/2024 8 P2106671, P2106673, P2106675, Exp 9/30/2024 9 P2200428, P2200429, P2200430, Exp 12/31/2024 10 P2203333, P2203334, Exp 5/31/2025 11 P2102940 Exp. 3/31/2023, P2105793, Exp. 7/31/2024 - Amount recalled
- 747,464 bottles
This recall covers 67 products
The agency filed one notice per product. You are reading one of them; the other 66 are below.
54 more are in the archive.
Where it was sold
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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